Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:

Study Purpose

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will:

(1) compare the effects of 1 mg/day phylloquinone vs.#46; placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis.

We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age ≥ 50 years.

- Male or post-menopausal female (no menses in the last year) - Plasma phylloquinone <1.0 nmol/L.

- Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?" - Kellgren-Lawrence (KL) grade 2-3 in at least one knee.

- Ability to understand study procedures and to comply with them for the entire length of the study.

- Ability to answer questions by phone.

- Ability to swallow capsules.

Exclusion Criteria:

- KL grade 4 in at least one knee.

- Inability to walk.

- Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17) - Widespread pain.

- Malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, Crohn's disease, celiac sprue) - Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation.

- Plan to permanently relocate from the greater Boston, MA or Chapel Hill NC areas during the trial period.

- Planned knee or hip arthroplasty during the study period.

- Undergoing cancer treatment.

- < 50 years old.

- Circulating phylloquinone ≥ 1.0 nmol/L.

- Warfarin (Jantoven) use.

- Use of other investigational drugs.

- Use of herbal, botanical or vitamin K supplements.

- Use of assistive walking devices

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05505552
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tufts University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Knee

Arms & Interventions

Arms

Experimental: Vitamin K

Participants receive 1 mg/d phylloquinone orally for 24 weeks

Placebo Comparator: Placebo

Participants receive daily placebo matching phylloquinone for 24 weeks

Interventions

Dietary Supplement: - Vitamin K

1 mg/day phylloquinone (vitamin K1)

Dietary Supplement: - Placebo

Placebo capsule once daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tufts University, Boston, Massachusetts

Status

Recruiting

Address

Tufts University

Boston, Massachusetts, 02111

Site Contact

Sarah Booth, PhD

[email protected]

617-556-3231

University of North Carolina Chapel Hill, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Richard Loeser, MD

[email protected]

617 556 3231

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